MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIAH SEG LOCK SCREW SET; PROSTHESIS, HIP

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: oss segmental femoral cat#:150355, lot#:919810; 150481 diah seg lock screw set lot 935180; 150419 oss non-mod tib plate long 63 lot # 612080; 150426 oss tib blk aug 10x63/67 univ lot # 896800; 150368 oss cemented im stem 14x150 lot # 691040; 150476 oss poly tibial bushing lot # 510910; 150477 oss poly femoral bushings 2pk lot # 780760; 150478 oss poly lock pin lot # 576750; 150412 oss tibial poly bearing 16mm lot # 231210; 150480 oss axle lot # 274490; 150493 oss reinforced yoke lot # 066340.Reported event was confirmed by review of the provided op notes.During the surgery, it was noted that an attempt was made to remove the distal screw from femoral component but it appeared to be cold welded and apparently was abandoned.Dhr was reviewed and no discrepancies relevant o the reported event were found.Review of the complaint history determined that no further action is required root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during the revision procedure, an attempt was made to remove the distal screw from femoral component but it appeared to be cold welded and was abandoned.

• Brand Name: DIAH SEG LOCK SCREW SET
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7167589
• MDR Text Key: 96722378
• Report Number: 0001825034-2018-00084
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 150481
• Device Lot Number: 935180
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 90